Director Global Drug Safety Product Leader

Proclinical is working with a global healthcare company that is seeking a Director Global Drug Safety Product Leader to be based in Switzerland on a permanent basis. The Global Biosimilars Safety Product Leader (BSPL) designs and implements tailored anticipatory safety strategies for the assigned biosimilar development candidates or marketed biosimilar products. The activities include providing recommendations and guidance concerning potential and/or established product risks and corresponding suitable risk management and mitigation strategies, ongoing comparative safety and benefit-risk evaluation such as the medical assessment of individual case safety records (ICSR), signal detection and evaluation activities, compilation of periodic safety reports, drafting of risk management plans and contributing to regulatory documents (e.g. briefing books, investigators brochure), or the design and conduct of post authorization safety studies (PASS) as advised.

Job Responsibilities:

• Conceive and implement a clearly defined tailored safety strategy that serves to characterize the comparative safety profile of the assigned biosimilar product(s) against the matching originator i.e. reference product(s).
• Appropriately monitor the emerging safety profile of the biosimilar product(s); this includes the review of ICSR, the conduct of signal detection and evaluation exercises, and the compilation and submission of required periodic reports.
• Conduct periodic signal detection and evaluation and escalate emerging safety signals or other notable safety findings to key stakeholders within the company.
• Assess the risk-benefit balance of the assigned biosimilar products and initiate suitable risk management and risk mitigation / minimization activities.
• Ensure that subject safety and the expected product safety specifications are appropriately considered during the design, conduct, analysis and reporting of clinical investigations. This includes securing suitable safety monitoring during study conduct, as well as inclusion of suitable risk management and mitigation measures.
• Maintain a comprehensive level of knowledge about the biosimilar product(s), the matching originator i.e. reference product and the therapeutic area
• Act as a qualified and informed back-up for other members of the CSPV team, as needed.
• Represent clinical safety and pharmacovigilance on cross-functional teams for the assigned biosimilar product(s) in such a way that all negotiated and agreed upon deliverables and deadlines for these teams are met (may be delegated as appropriate).
• Represent clinical safety and pharmacovigilance with respect to the assigned biosimilar product(s) externally, e.g. engagement with DSMBs / IDMCs. Contribute to and participate in health authority / regulatory agency meetings, interact with external advisers or opinion leaders, collaborate with colleagues from partnering companies (e.g. co-development or co-marketing).
• Provide product or disease area training with respect to the safety specifications of the assigned biosimilar product(s) and offer training on clinical safety and pharmacovigilance methodology to colleagues from other functions, as required.
• Communicate clearly and effectively during health authority / regulatory agency inspections concerning process and product-related aspects of the management of clinical safety and pharmacovigilance. Able to describe accountabilities and responsibilities accurately and succinctly when asked to by inspectors during pharmacovigilance or other regulatory authority inspections

Skills and Requirements:

• Clinically versed MD with significant experience in pharmaceutical medicine (drug development and/or drug safety/pharmacovigilance)
• Excellent verbal and written communication skills (in English language)
• Industry experience, preferably including both clinical development and pharmacovigilance experience (including medical safety evaluation and safety-based decision making)
• Excellent knowledge of product development process and experience of cross-functional team work.
• Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files
• First-hand experience in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, haematological) and good understanding of either the oncology or rheumatology therapeutic area
• Professional experience in an international environment
• Several years of industry experience (minimum 5 years)
• Strong, mature project leadership and influencing skills
• Entrepreneurial thinking and striving to move project forward, within budget and timelines
• Strong team player and excellent networking skills

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jon Stewart on +44 203 7520 318 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.